FDA.reportPublic FDA data

AZOLEN

Manufacturer
STRATUS PHARMACEUTICALS INC | TARMAC PRODUCTS INC
Effective date
2024-10-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:32:49

Label at a glance#

ProductAZOLEN
Active ingredientMICONAZOLE NITRATE
Label structure11 sections

Indications and uses

For the treatment of most: athlete's foot jock itch ringworm Relieves: itching scaling cracking burning redness discomfort

Dosage and administration

Wash the affected area well with AZOLEN Anti-Fungal Wash and let product sit 1-2 minutes before rinsing Dry the affected area thoroughly Apply the product over the affected area twice daily (morning and night) or as directed by a doctor Supervise children in the use of this product For athlete's foot: Pay special attention to spaces between toes; wear well-fitting, ventilated shoes, and change shoes and socks at l...

Storage and handling

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F) [See USP Controlled Room Temperature]

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Miconazole Nitrate 2%

Purpose

OTC - PURPOSE SECTION

Topical Antifungal

Uses

INDICATIONS & USAGE SECTION

  • For the treatment of most:
    • athlete's foot
    • jock itch
    • ringworm
  • Relieves:
    • itching
    • scaling
    • cracking
    • burning
    • redness
    • discomfort

Warnings

WARNINGS SECTION

for external use only

Do not use

OTC - DO NOT USE SECTION

  • on children under 2 years of age unless directed by a doctor
  • for diaper rash

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation occurs
  • there is no improvement within 2 weeks (for jock itch)
  • there is no improvement within 4 weeks (for athlete's foot and ringworm)

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center immediately

Directions

DOSAGE & ADMINISTRATION SECTION

  • Wash the affected area well with AZOLEN Anti-Fungal Wash and let product sit 1-2 minutes before rinsing
  • Dry the affected area thoroughly
  • Apply the product over the affected area twice daily (morning and night) or as directed by a doctor
  • Supervise children in the use of this product
  • For athlete's foot: Pay special attention to spaces between toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
  • For athlete's foot and ringworm, use daily for 4 weeks
  • For jock itch, use daily for 2 weeks. If condition persists longer, consult a doctor
  • This product is not effective on scalp or nails

Other Information

STORAGE AND HANDLING SECTION

  • Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F) [See USP Controlled Room Temperature]

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Lauramidopropyl Betaine, Laureth-7, Panthenol, Phospholipid EFA, Purified Water, Sodium Chloride, Sodium C14-16 Olefin Sulfonate, Tea Tree Oil.

Questions or Comments?

OTC - QUESTIONS SECTION

Call us at 1-800-442-7882

SPL UNCLASSIFIED SECTION

Distributed by:
Stratus Pharmaceuticals Inc.
Miami, FL 33186

PRINCIPAL DISPLAY PANEL - 170 g Bottle Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 58980-819-60

AZOLEN™
ANTI-FUNGAL WASH

(MICONAZOLE NITRATE 2%)

NOW TREAT
JOCK ITCH IN
THE SHOWER

SOOTHES AND
CONTROLS MOST:*
JOCK ITCH
ATHLETE'S FOOT
RINGWORM

STRATUS
PHARMACEUTICALS INC

Net Wt 6 oz (170 g)

Principal Display Panel - 170 g Bottle Box
Principal Display Panel - 170 g Bottle Box

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
MICONAZOLE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58980-819-60AZOLEN170 g in 1 BOTTLELIQUID1702
58980-819-60AZOLEN1 in 1 BOXLIQUID12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58980-819AZOLEN (MICONAZOLE NITRATE) LIQUID [STRATUS PHARMACEUTICALS INC]2Current NDC, 2 package rows20241102_3264bd0a-c628-404b-8c09-8586682d054e.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58980-81958980-819-60

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
MICONAZOLE NITRATEVW4H1CYW1KACTIB
SODIUM CHLORIDE451W47IQ8XIACT
PANTHENOLWV9CM0O67ZIACT
TEA TREE OILVIF565UC2GIACT
LAURETH-7Z95S6G8201IACT
SODIUM C14-16 OLEFIN SULFONATEO9W3D3YF5UIACT
LAURAMIDOPROPYL BETAINE23D6XVI233IACT
LINOLEAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE5Q87K461JOIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AZOLENMICONAZOLE NITRATESTRATUS PHARMACEUTICALS INC3264bd0a-c628-404b-8c09-8586682d054e2024-10-31WarningsExact identifier
ndc (package): 58980-819-60
ndc (product): 58980-819
ndc11 (package): 58980081960
spl id: 85b974c1-bef2-4320-93a4-0fcf7774c55c
spl set id: 3264bd0a-c628-404b-8c09-8586682d054e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.